News | January 08, 2026
Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy
REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS
REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL
The approval introduces a needle-free alternative to injectable GLP-1 therapies
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
CystoSmart, an AI tool designed to detect bladder tumors during screening and surveillance cystoscopy, is brand-agnostic and works with flexible, rigid, and single-use scopes
The company said it received notice on January 1 from the FDA’s Center for Veterinary Medicine that the funding will support its ongoing effectiveness study of Canalevia-CA1
The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
The approval is supported by data from three pivotal clinical trials
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